Registration Dossier
Registration Dossier
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EC number: 407-330-8 | CAS number: 61571-06-0
Endpoint summary
Administrative data
Description of key information
Skin
In vivo
Rabbit: not irritating (OECD 404, BASF AG 1984)
Rabbit: not irritating (OECD 404, BASF AG 1986)
In vitro
Actually, there is no information available to cover this endpoint.
Eye
In vivo
Rabbit: not irritating (OECD 405, BASF AG 1991)
In vitro
Actually, there is no information available to cover this endpoint.
Respiratory system
Actually, there is no information available to cover this endpoint.
Key value for chemical safety assessment
Additional information
Skin
The potential of the test substance to cause acute dermal irritation or corrosion was assessed in two studies with rabbits in vivo. In these studies using the purified test substance or the distillation residues the unchanged test material was applied for 4 hours to the shaved skin of 3 animals under semiocclusive conditions and the animals were observed for several days. The test substance caused a mean erythema score of 0.7 (maximum score possible: 4) and a mean edema score of 0.1 (maximum score possible: 4) with the purified test material and a mean erythema score of 0.0 (maximum score possible: 4) and a mean edema score of 0.0 (maximum score possible: 4) with the distillation residues calculated for all animals for the readings at 24, 48 and 72 hours. The erythema scores were fully reversible 8 days after application of purified product as well as with the distillation residues and therefore the studies were terminated earlier as recommended by the guideline. No findings were noted at necropsy in both studies.
Eye
The potential of the test substance to cause acute eye irritation or corrosion was assessed in three Vienna White rabbits in vivo according to OECD guideline 405. In this study 3 rabbits were treated with the undiluted purified test substance for 24 hours and findings were recorded for a total observation period of 8 days. Lesions of the conjunctiva were moderate (redness) or slight to moderate (chemosis) in all animals between 24 and 72 hours returning to normal on day 8 of the study in all animals; corneal opacity was slight in all animals between 24 and 72 hours, persisting till the end of the study in one animal. Only slight reactions were recorded for the iritis persisting in two animal for 72 hours, the third animal showed reactions only on day one and two. In summary, a total reversibility of the findings was noted in 2 animals whereas in the third one (i.e. animal 2), corneal opacity persisted until the end of the study on day 8. The mean scores observed for all animals between 24 and 72 hours were 1.2 for chemosis, 2 for redness of conjunctiva, 1 for corneal opacity and 0.7 for iritis. Based on these results the test substance was judged irritating by the authors.
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Respiratory system
Actually, there is no information available to cover this endpoint.
Justification for classification or non-classification
Skin
Based on the results of the in vivo experiment, the test substance needs not to be labelled according to the criteria defined by the EU and the GHS system.
Eye
The test substance has been classified and labelled with “R41 - Risk of serious damage to eyes” according Index 606-062-00-0, EC 1272/2008.
Respiratory system
Actually, there is no indication given for a classification according to this endpoint.
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